Prescription drug · ANDA
Ulspira NDC 82605-006
Nitric oxide .8 mL/100L · Gas · Respiratory (Inhalation) · Airgas Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82605-006-01 | 82605000601 | 2138 L in 1 CYLINDER (82605-006-01)Marketed from Aug 4, 2023 | |
| 82605-006-02 | 82605000602 | 362 L in 1 CYLINDER (82605-006-02)Marketed from Aug 4, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ulspira
- Generic name (nonproprietary)
- ulspira
- Active ingredients
- Nitric oxide — .8 mL/100L
- Dosage form
- Gas
- Route
- Respiratory (Inhalation)
- Labeler
- Airgas Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203144
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91SPL ID 3a136eac-7cc3-31ea-e063-6294a90afb91SPL set ID 026e4541-63fa-aebc-e063-6294a90abaeaRxCUI 582608UNII 31C4KY9ESHUPC 0082605006021, 0082605006014
- Pharmacologic class
- Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N482605000601followed by a unit qualifier and the quantityPackage 82605-0006-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ULSPIRA™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. ULSPIRA is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near- term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203144
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ulspiranitric oxide | Nitric oxide .8 mL/100L | GasRespiratory (Inhalation) | Airgas Therapeutics, LLC | 82605-008 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.